Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02
Information source: International Breast Cancer Study Group
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Osteoporosis
Intervention: laboratory biomarker analysis (Other); dual x-ray absorptiometry (Procedure)
Phase: Phase 3
Sponsored by: International Breast Cancer Study Group
Official(s) and/or principal investigator(s):
Olivia Pagani, MD, Study Chair, Affiliation: Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
RATIONALE: Gathering information over time from bone density and laboratory tests of women
with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study
of breast cancer in the future.
PURPOSE: This clinical trial is studying changes in bone mineral density in women with
breast cancer treated with triptorelin and tamoxifen or exemestane on protocol IBC SG-25-02
Official title: TEXT-Bone: A Substudy of the TEXT Trial to Evaluate Serial Bone Markers for Bone Remodeling, Serial Growth Factors, and Bone Mineral Density
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase
Serial serum levels of IGF-1 and IGFBP-3
Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)
- Evaluate changes in bone mineral density (BMD) among premenopausal women randomized in
protocol IBC SG-25202 (TEXT-2) to receive either: A) triptorelin (GnRH analogue) for 5
years plus tamoxifen for 5 years; or B) triptorelin (GnRH analogue) for 5 years plus
the steroidal aromatase inhibitor exemestane for 5 years.
- Evaluate serial serum markers for bone remodeling (C-telopeptide, osteocalcin,
bone-specific alkaline phosphatase) and investigate their correlation with BMD.
- Evaluate the relationship of genetic variants of CYP19A1, ERα, ERß, and IGF 1 with BMD.
- Evaluate serial serum growth factors (IGF-1 and IGFBP-3) and investigate whether their
time course correlates with BMD.
- Explore the role of serum IGF-1 and IGFBP-3 as biomarkers of disease outcome
(disease-free survival). (exploratory)
OUTLINE: Blood samples are collected at baseline and then periodically for 6 years. Serum
markers of bone remodeling and serum growth factor levels are measured.
Bone mineral density in the L1-L4 (postero-anterior) region of the spine and femoral neck of
the hip is measured by DEXA at baseline and then periodically for 6 years.
Any surplus serum is stored for use in unspecified future research.
Minimum age: 18 Years.
Maximum age: N/A.
- Patient must be eligible and enrolled in the TEXT-2 trial prior to enrolling in
- Serial bone marrow density (BMD) measurements must be taken within the same
- Hormone receptor positive
- See Disease Characteristics
- No bone fracture in the past 6 months that, in the investigator's judgement, could be
related to bone fragility
- No clinical or biochemical malabsorption syndrome, known vitamin D deficiency, active
hyper- or hypoparathyroidism, or Paget's disease
- No uncontrolled thyroid disease, Cushing disease, or other pituitary diseases
- No other bone disease (including osteomalacia or osteogenesis imperfecta)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 months since prior and no concurrent bisphosphonate therapy (or other bone
therapies such as PTH or strontium)
- At least 6 months since prior glucocorticoid (> 5 mg prednisone or equivalent) for >
- At least 12 months since prior anticonvulsants
Locations and Contacts
Oncology Institute of Southern Switzerland, Bellinzona CH-6500, Switzerland; Recruiting
Olivia Pagani, MD, Phone: 41-91-820-9111, Email: firstname.lastname@example.org
Tom Baker Cancer Centre - Calgary, Calgary, Alberta T2N 4N2, Canada; Recruiting
Barbara A. Walley, MD, FRCPC, Phone: 403-521-3688, Email: email@example.com
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 2009
Last updated: July 26, 2012